Hepatic Impairment
Conditions
Keywords
Mezigdomide, BMS-986348, CC-92480
Brief summary
The aim of this study is to measure the concentration levels of mezigdomide in the blood of participants with mild, moderate, and severe hepatic impairment, and in matched healthy control participants with normal hepatic function.
Interventions
DRUGMezigdomide
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Hepatic Impaired Participants: * Participants have mild, moderate, or severe hepatic impairment or cirrhosis due to chronic hepatic disease and/or prior alcohol use. * Participants have mild (Group A), moderate (Group B), or severe (Group C) hepatic impairment as defined by Child-Pugh Score. Matched Healthy Participants: * Participant must be free of any clinically significant disease that would interfere with the study evaluations. * Participant must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the investigator.
Exclusion criteria
All Participants: * History of chronic pruritus or dermatologic syndromes that may be confounded with reactions to mezigdomide. * Contraindication or intolerance to first-generation antihistamine medications. Hepatic Impaired Participants: -Clinical laboratory test results: * Platelet count lower than 30,000/microliter (μL) at screening or Day -1. * Absolute neutrophil counts lower than 1,500/μL at screening or Day -1. Matched Healthy Participants: -History of or suspected benign ethnic neutropenia. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed concentration (Cmax) | Up to 6 days |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T]) | Up to 6 days |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Up to 6 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with vital sign abnormalities | Up to 6 days |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 6 days |
| Number of participants with adverse events (AEs) | Up to 6 days |
| Metabolic ratio of AUC(0-T) | Up to 6 days |
| Metabolic ratio of AUC(0-INF) | Up to 6 days |
| Number of participants with clinical laboratory abnormalities | Up to 6 days |
| Number of participants with serious adverse events (SAEs) | Up to 6 days |
| Number of participants with physical examination abnormalities | Up to 6 days |
Countries
United States
Outcome results
None listed